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法规知识库 · EMA 集中审评

Blitzima

rituximab · EMEA/H/C/004723 · 已授权

生物类似药

获批上市许可

2017-07-13

欧委会决定日

2025-09-25

持有人 / 申请人

Celltrion Healthcare Hungary Kft.

终止日期字段

无

从产品到官方文件

文件记录

9

官方索引 9

EPAR / 审评

7

assessment / overview 等

产品信息

2

PI / presentations

其他

0

RMP / PIP 等

ATC:L01FA01

治疗领域:Lymphoma, Non-Hodgkin;Leukemia, Lymphocytic, Chronic, B-Cell

药理分类:Antineoplastic agents

修订号:24 · 最新影响 PI 的程序:VR/0000290253

适应症(原文):Blitzima is indicated in adults for the following indications: Non-Hodgkin’s lymphoma (NHL) Blitzima is indicated for the treatment of previously untreated patients with stage III-IV follicular lymphoma in combination with chemotherapy. Blitzima maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy. Blitzima monotherapy is indicated for treatment of patients with stage III-IV follicular lymphoma who are chemo-resistant or are in their second or subsequent relapse after chemotherapy. Blitzima is indicated for the treatment of patients with CD20 positive diffuse large B cell non-Hodgkin’s lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy. Chronic lymphocytic leukaemia (CLL) Blitzima in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory CLL. Only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including Blitzima or patients refractory to previous Blitzima plus chemotherapy.

关键日期时间轴

来自 EMA medicines JSON 日期字段;缺失字段不展示,不补推结论。

  1. 2025-09-25 · 欧委会决定

  2. 2017-07-13 · 获批上市许可

  3. 2017-05-18 · CHMP 意见通过

说明书、EPAR 与其他文件

仅展示 EMA 官方 document_url;本站不下载或镜像 PDF。

EPAR / 审评资料 7产品信息 2其他 0

EPAR / 审评资料

  • Blitzima : EPAR - Procedural steps taken and scientific information after authorisation

    procedural-steps-after · 2025-09-29

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  • Blitzima : EPAR - Procedural steps taken and scientific information after authorisation (archive)

    procedural-steps-after · 2024-12-09

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  • Blitzima-H-C-PSUSA-00002652-202211 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)

    scientific-conclusion · 2023-11-29 · EMA/540498/2023

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  • Blitzima-H-C-PSUSA-00002652-202111 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)

    variation-report · 2022-09-01 · EMA/592634/2022

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  • Blitzima-H-C-PSUSA-00002652-202011 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

    scientific-conclusion · 2021-09-15 · EMA/403185/2021

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  • Blitzima : EPAR - Summary for the public

    overview · 2021-01-07 · EMA/563275/2020

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  • Blitzima : EPAR - Public assessment report

    assessment-report · 2017-08-17 · EMA/CHMP/421793/2017

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产品信息

数据来自 EMA 官方 JSON;最终以 EMA / 欧委会文件为准。本页不自动给出安全或非安全结论。